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Nonclinical Topics – Project Volunteer Board

Nonclinical Topics – Project Volunteer Board

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Welcome!

Welcome!

Interested in joining one of the Nonclinical Topics Working Group Projects? The projects below welcome new volunteers.

Nonclinical Study Data Reviewer's Guide

Project Scope:

This project is to evolve the Nonclinical Study Data Reviewer's Guide (nSDRG), based on comments from a public PHUSE review, plus to adapt it to updates of the FDA Technical Conformance Guide. The project continues to check and align with the SDRG template and guide developed by the Optimizing the Use of Data Standards Working Group for clinical studies.

Preparation of a Study Data Reviewer’s Guide (SDRG) is recommended as an integral part of a CDISC standards-compliant study data submission. The challenge is to operationalise this new documentation requirement efficiently and effectively.

Challenges we seek to answer with this project:

  • Provide a practical template for easy access and use

  • Provide guidance document which describes expected content and options to guide nonclinical SDRG authors.

  • Provide authors with examples, describing how to handle different data situations with SDRG content.

Things we expect to learn along the way:

  • Exploration of ways to generate the nonclinical SDRG and who should do the job.

  • The SDRG is expected to be useful by FDA reviewers. Can it also be useful for other nonclinical study stakeholders?

  • Will the SDRG evolve as systems and processes gain expertise in the new SEND requirements for submission of nonclinical data?

Regular Project Meeting Day/Time:

  • Monthly: Last Thursday of the month 16:00-17:00 GMT

Key Skills:

  • Experience with the SDRG

  • Knowledge on the FDA's Technical Conformance Guide

  • Review and respond to recent informal feedback from the FDA on the next version of the nSDRG template

  • Develop nSDRG examples of SEND IG 4.0 POC datasets

SEND Industry Feedback Survey

Project Scope:

Execute an annual survey process to objectively collect data that enables detection of impactful issues and trends (both good and bad) that can be acted upon by the PHUSE community

The survey will:

  • provide SDOs with actionable information regarding improvements to their standards.

  • enable CROs, software developers and data service providers, with extensive data management experience, an opportunity to provide actionable recommendations

  • provide Sponsors with information on how they can better leverage their SEND investments.

Results of the survey will be presented at the PHUSE Nonclinical Event.

Regular Project Meeting Day/Time:

  • Bi-weekly: Thursdays 14:00-15:00 GMT

Key Skills:

  • Collaboration with other industry leaders 

  • Critical thinking of current and key SEND topics

  • Knowledge of upcoming changes in the nonclinical industry 

  • Experience with other industry groups and forums